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Welcome to SVA’s jobs portal, your one-stop shop for finding the most up to date source of employment opportunities. We have partnered with the National Labor Exchange to provide you this information. You may be looking for part-time employment to supplement your income while you are in school. You might be looking for an internship to add experience to your resume. And you may be completing your training ready to start a new career. This site has all of those types of jobs.

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Boehringer Ingelheim Pharmacovigilance Manager, Clinical Support - Study Start Up (Hybrid) in Ridgefield, Connecticut

Description

Responsible for implementing and maintaining global reporting practices for clinical adverse events, including, data collection and delivery, reconciliation and medical terminology coding for all program types including but not limited to clinical trials, non-interventional studies (NIS), Investigator Initiated Studies (IIS), Non Trial Activities (NTAs). Provide support to all functional areas within Global Pharmacovigilance (GPV) as well as external to GPV, including Clinical Operations, Medical Affairs, Biostatistics and Data Sciences (BDS), Health Economics Outcomes Research (HEOR), Global Regulatory Affairs, Commercial/Marketing teams, etc. in areas of adverse event report management, including reconciliation activities. Determine and communicate impact of AE volume, program complexity of all program types on GPV resources. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

This is a hybrid position which requires 2 days a week onsite at our Ridgefield, CT campus.

Duties & Responsibilities

  • Under the direction of the Global Pharmacovigilance Operations Leadership, ensures that objectives of the department are met. Develop common processes for AE and SAE data collection and delivery, including Safety Data Exchange Agreements (SDEAs), reconciliation, drug and event coding, adverse event reporting, adverse event report training and resource planning in collaboration with Clinical Operations, Medical Affairs, BDS, HEOR, Global Regulatory Affairs, Commercial teams, etc.

  • Collect and analyze data on clinical and marketing projects for use in GPV resource planning.

  • Indicator: Collaborate with clinical, medical affairs and commercial/marketing teams. Collect relevant data on clinical and marketing projects and communicate to GPV management.

  • Act as subject matter expert in areas of adverse event collection processes and regulatory reporting practices.

  • Collaborate with GPV Risk Management Physicians to confirm accuracy of adverse event information reported and collected.

  • Participate in the study development and startup activities for both clinical trial and non-trial activities. Communicate complex safety related issues to management. Ensure that all CRO/supplier agreements contain the appropriate PV clause/language.

  • Participate in departmental projects/activities as deemed appropriate. Provide support to case processing teams where appropriate.

Requirements

  • BS degree or higher in nursing, pharmacy or related health care field from an accredited institution preferred.

  • Minimum of three (3) years of relevant clinical practice in an acute care setting (preferred)

  • Minimum of three to five (3-5) years of pharmaceutical industry experience, with two (2) years of experience processing adverse event information preferred.

  • Working knowledge of FDA regulations preferred.

  • Ability to make decisions independently.

  • Ability to prioritize workload and perform under stress in situations in which working speed and sustained attention are critical aspects of the job.

  • Application of medical knowledge to collect, interpret and reconcile medical information in order to precisely capture the adverse event as reported.

  • Must be able to communicate and resolve issues effectively with inter/intra departments through strong interpersonal skills.

  • Proficient in electronic data capture tools (e.g. ARISg) and Microsoft-based applications.

  • Must have problem solving skills and the ability to organize time effectively

  • In addition to understanding all company policies, guidelines and working instructions regarding the reporting of adverse events, the incumbent must be familiar with clinical trial protocols, product labels, company core data sheets, investigator brochures, medical terminology dictionaries and federal regulations.

  • Ability to make timely and informed decisions, work independently and prioritize daily workload and assigned projects will play a critical factor for success.

Compensation

This position offers a base salary typically between $111,000 and $183,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please click here. (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards)

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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